OncoMatch/Clinical Trials/NCT06826768
A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC
Is NCT06826768 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including REGN5678 and Cemiplimab for prostate cancer.
Treatment: REGN5678 · Cemiplimab — A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: antiandrogen — second-generation
disease progression after at least two lines of systemic therapy, including one line of second-generation anti-androgen therapy
Lab requirements
Blood counts
Hemoglobin ≥8.5 g/dL; ANC ≥1.0 x 10^9/L; Platelet count ≥100 x 10^9/L
Kidney function
Serum creatinine ≤1.5 x ULN or estimated GFR >50 mL/min/1.73 m2
Liver function
Total bilirubin ≤1.5 x ULN (except Gilbert's syndrome); AST ≤2.5 x ULN; ALT ≤2.5 x ULN; ALP ≤2.5 x ULN (≤5 x ULN if tumor liver or bone involvement)
Adequate organ and bone marrow function documented by: Hemoglobin ≥8.5 g/dL; ANC ≥1.0 x 10^9/L; Platelet count ≥100 x 10^9/L. Serum creatinine ≤1.5 x ULN or estimated GFR >50 mL/min/1.73 m2. Adequate hepatic function: Total bilirubin ≤1.5 x ULN; AST ≤2.5 x ULN; ALT ≤2.5 x ULN; ALP ≤2.5 x ULN (≤5 x ULN if tumor liver or bone involvement).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas M. D. Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06826768 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received antiandrogen.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages